Shire and Johnson & Johnson have won the backing of the European Court of Justice for data exclusivity against a generic rival, Generics UK, for the Alzheimer’s drug Reminyl.
The court ruled that a product approved in a country before it joined the EU, and not since upgraded, could not be used for a generic product application.
Generics UK based its application for a generic version of Reminyl on the active ingredient Nivalin, which was approved in Austria in 1963 before the country joined the EU.
UK company Shire co-markets Reminyl in Europe with Janssen-Cilag AB, a unit of Johnson & Johnson.